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Heated chemotherapy showdown: which works better for abdominal cancer spread?

NCT ID NCT01815359

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two ways of giving chemotherapy directly into the belly after surgery to remove visible cancer from the lining of the abdomen. The cancer comes from the appendix, colon, or rectum. About 292 adults will be randomly assigned to receive either early post-operative chemotherapy (EPIC) or heated chemotherapy (HIPEC) during surgery. The goal is to see which approach helps people stay cancer-free longer and has fewer side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

292 people

The number who actually took part.

Start date

Mar 2013

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient's age 18 years or older, both genders. * Clinical diagnosis of appendiceal or colorectal neoplasm with peritoneal mucinosis or metastasis. * Patient must be planning to undergo complete cytoreduction of all peritoneal disease. * ECOG performance status ≤ 1. * Hematology: ANC ≥ 1,500/ μL; Platelets \> 75,000/ μL. * Adequate Renal function Creatinine \<1.5 x the upper limit of normal (ULN) or calculated creatinine clearance of ≥ 50ml/min. * Adequate Hepatic function: Bilirubin less than 1.5mg/dL; (except in patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0mg/dL). * Women with childbearing potential who are negative for pregnancy test (urine or blood) and who agree to use effective contraceptive method. Reliable contraception should be used from trial screening and must be continued throughout the study. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. * A man participating in this study must agree to utilize reliable barrier form of contraception for the duration of the study. * Signed and dated written informed consent to participate in this clinical trial must be obtained prior to any study procedure. * Subjects with a history of endometrial cancer are eligible only if they presented with a stage lower than 1A and if the histology was a subtype other than poorly differentiated. Exclusion Criteria: * Subjects who have previously undergone intraperitoneal chemotherapy. * Subjects with classical carcinoid * Tumors of low malignant potential * Other prior malignancies, except for cured non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix, adequately treated malignancies for which there has been no evidence of activity for more than 3 years or indolent tumors for which observation over three years is a reasonable option. * Presence of clinically apparent or suspected metastasis to sites other than lymph nodes or peritoneal surfaces. * Women who are pregnant or lactating. * Subjects with a condition which may interfere with the subjects' ability to understand the requirements of the study. * Active coronary artery disease (defined as unstable angina or a positive cardiac stress test). * Subjects with a history of coronary artery disease may be included if they have had a normal stress test within 60 days of enrollment and/or were cleared by MSK cardiology. * Uncontrolled hypertension defined as \>140/90 and not cleared for surgery at the time of consent. * New York Heart Association (NYHA) Class II or higher Congestive heart failure. * Restrictive or obstructive pulmonary disease that would limit study compliance or place the patient at unacceptable risk for participation in the study. * History of cerebrovascular disease. that would limit study compliance or place the patient at unacceptable risk for participation in the study. * Subjects with other concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or places them at an unacceptable risk for participation in the study. * Patients with known floxuridine, leucovorin ,or mitomycin allergy. * Evidence of extensive intraperitoneal adhesions at the time of surgery which prohibits intraperitoneal therapy, as determined by the operating surgeon. * Any condition that would preclude the ability to deliver appropriate IP therapy. * Use of an oral medication, lacking a suitable non-oral substitute, that if held for up to ten days, would be felt an unacceptable risk by the investigator. * Life expectancy \< 12 weeks.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Memorial Sloan Kettering Basking Ridge (Consent and Follow up)

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen (Consent and Follow up)

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack (Consent and Follow up)

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth (Consent and Follow up)

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau (Consent and Follow up)

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester (Consent and Follow up)

    Harrison, New York, 10604, United States

  • University of Miami

    Miami, Florida, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.